Back to resultsPediatric Helmet CPAP Pilot Study
Primary Purpose
Bronchiolitis, Viral, Pneumonia, Viral, Pneumonia, Bacterial
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helmet CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis, Viral
Eligibility Criteria
Inclusion Criteria:
- One month to 5 years of age (inclusive) admitted to the PICU with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask CPAP for at least four hours but less than 48 hours, and parental informed consent.
Exclusion Criteria:
- Age less than 1 month or greater than 5 years
- Positive for COVID-19
- Need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (BPAP)
- Unresponsiveness (GCS 8 or less)
- Hypotension as defined as a systolic blood pressure less than 5th percentile for age
- Existing head or neck trauma, known or suspected air leak syndrome (pneumothorax, pneumomediastinum, subcutaneous emphysema), known or suspected increased intracranial pressure
- Non-English speaking parent
Sites / Locations
- Columbia University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Helmet CPAP
Arm Description
Patients in the Pediatric Intensive Care Unit (PICU) already receiving CPAP through a facemask or nasal prongs or mask for at least four hours but no more than 48 hours will be transitioned to the Vyatil nonpowered oxygen tent system (Rochester, NY) by trained respiratory therapists per the manufacture's instructions: patient's neck circumference will be measured with a soft tape measure to ensure appropriate sizing. The helmet will be connected to at least 30 liters per minute of high flow medical air with an oxygen blender. The expiratory limb will be attached to the positive end expiratory pressure (PEEP) valve (initially set at 5 centimeters of water pressure) connected to a high-efficiency particulate air (HEPA) filter to prevent any viral particles from being released into the environment. A disposable manometer will be used to measure the pressure within the helmet. Once the flow to the helmet interface is on, the helmet will be sealed and secured with the system's arm straps.
Outcomes
Primary Outcome Measures
Tolerability of helmet CPAP
Percentage of patients that tolerate helmet CPAP for at least four hours. Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (>5 minutes) removals or disruptions.
Secondary Outcome Measures
Respiratory rate
We will measure respiratory rate in breaths per minute every hour blood pressure every hour for four hours.
Heart rate
We will measure heart rate in beats per minute every hour
Oxygen saturation
We will measure pulse oxygen saturation as a percent every hour
Systolic blood pressure
We will measure systolic blood pressure in millimeters of mercury every hour
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04764929
Brief Title
Pediatric Helmet CPAP Pilot Study
Official Title
Helmet CPAP for Infants and Pediatric Patients With Acute Respiratory Distress
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick Wilson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPAP can help kids with lung infections breathe easier. The machine delivers pressurized air, which may help people with lung infections breathe more easily. Doctors routinely use a Facemask, Nasal Mask or Nasal Prongs to give CPAP for kids with lung infections, but the researchers want to know whether using Helmet CPAP is the same or better.
Detailed Description
Prior clinical trials have demonstrated efficacy of Helmet CPAP in adults with acute respiratory distress syndrome, superior tolerance and improved respiratory scores compared to nasal/facial CPAP in infants, and no major safety concerns were identified with the use of helmet CPAP. This is a prospective pilot study to (1) determine if infants and pediatric patients requiring CPAP in the PICU will tolerate helmet CPAP for at least four hours, and (2) measure changes in the respiratory rate, oxygen saturation, heart rate and blood pressure over four hours. If helmet CPAP is found to be well tolerated in this small cohort, a larger study comparing it directly to other CPAP interfaces will be conducted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Viral, Pneumonia, Viral, Pneumonia, Bacterial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Helmet CPAP
Arm Type
Experimental
Arm Description
Patients in the Pediatric Intensive Care Unit (PICU) already receiving CPAP through a facemask or nasal prongs or mask for at least four hours but no more than 48 hours will be transitioned to the Vyatil nonpowered oxygen tent system (Rochester, NY) by trained respiratory therapists per the manufacture's instructions: patient's neck circumference will be measured with a soft tape measure to ensure appropriate sizing. The helmet will be connected to at least 30 liters per minute of high flow medical air with an oxygen blender. The expiratory limb will be attached to the positive end expiratory pressure (PEEP) valve (initially set at 5 centimeters of water pressure) connected to a high-efficiency particulate air (HEPA) filter to prevent any viral particles from being released into the environment. A disposable manometer will be used to measure the pressure within the helmet. Once the flow to the helmet interface is on, the helmet will be sealed and secured with the system's arm straps.
Intervention Type
Device
Intervention Name(s)
Helmet CPAP
Intervention Description
Vyatil nonpowered oxygen tent system
Primary Outcome Measure Information:
Title
Tolerability of helmet CPAP
Description
Percentage of patients that tolerate helmet CPAP for at least four hours. Tolerance is defined as the successful application and maintenance of helmet CPAP without any unplanned, prolonged (>5 minutes) removals or disruptions.
Time Frame
Four hours
Secondary Outcome Measure Information:
Title
Respiratory rate
Description
We will measure respiratory rate in breaths per minute every hour blood pressure every hour for four hours.
Time Frame
Four hours
Title
Heart rate
Description
We will measure heart rate in beats per minute every hour
Time Frame
Four hours
Title
Oxygen saturation
Description
We will measure pulse oxygen saturation as a percent every hour
Time Frame
Four hours
Title
Systolic blood pressure
Description
We will measure systolic blood pressure in millimeters of mercury every hour
Time Frame
Four hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
One month to 5 years of age (inclusive) admitted to the PICU with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask CPAP for at least four hours but less than 48 hours, and parental informed consent.
Exclusion Criteria:
Age less than 1 month or greater than 5 years
Positive for COVID-19
Need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (BPAP)
Unresponsiveness (GCS 8 or less)
Hypotension as defined as a systolic blood pressure less than 5th percentile for age
Existing head or neck trauma, known or suspected air leak syndrome (pneumothorax, pneumomediastinum, subcutaneous emphysema), known or suspected increased intracranial pressure
Non-English speaking parent
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick T Wilson, MD
Phone
212-305-8458
Email
ptw2107@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Patrick T Wilson, MD
First Name & Middle Initial & Last Name & Degree
Meghan Gray, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pilot study
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Pediatric Helmet CPAP Pilot Study
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